A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase 2, Multicenter, Open-label, Single Arm Study of Lenalidomide (CC-5013) in Combination With Low-dose Dexamethasone in Japanese Patients With Previously Untreated Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698801
• Other study ID #: CC-5013-MM-025
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2012
• Est. completion date: June 26, 2018

Study information

• Verified date: October 2018
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 26, 2018
• Est. primary completion date: November 26, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age = 20 years at the time of signing the informed consent document

• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted

• Able to adhere to the study visit schedule and other protocol requirements

• Previously untreated, symptomatic multiple myeloma

• Have measurable disease by protein electrophoresis analyses

• At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

• Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan

Exclusion Criteria:

• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study

• Any condition that confounds the ability to interpret data from the study

• Previous treatment with anti-myeloma therapy

• Pregnant or lactating females

• Any of the following laboratory abnormalities:

• Absolute neutrophil count (ANC) < 1,000/microL (1.0 × 10^9/L )

• Untransfused platelet count (a platelet count drawn at least 7 days after the administration of the last platelet transfusion) < 50,000 cells/microL (50 × 10^9/L)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 × upper limit of normal

• Renal failure requiring hemodialysis or peritoneal dialysis

• Prior history of malignancies, other than MM, unless the subject has been free of the disease for = 5 years

• Subjects who are unable or unwilling to undergo antithrombotic therapy.

• Peripheral neuropathy of = grade 2 severity.

• Uncontrolled systemic fungal, bacterial, or viral infection

• Known human immunodeficiency virus (HIV) positivity (subjects who are receiving antiretroviral therapy for HIV disease)

• Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a Hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded.

• Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.

• Ineligible for dexamethasone or dexamethasone is contraindicated.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Lenalidomide
25 mg oral lenalidomide once daily on Days 1-21 of each 28-day cycle
• dexamethasone
40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle

Locations

Country	Name	City	State
Japan	Hitachi General Hospital	Hitachi	Ibaraki
Japan	Tokai University Hospital	Isehara	Kanagawa
Japan	Kagoshima Medical Center	Kagoshima
Japan	Kameda Medical Center	Kamogawa	Chiba
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	University Hospital, Kyoto Prefectural University of Medicine	Kyoto
Japan	Iwate Medical University	Morioka	Iwate
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Nagoya Daini Red Cross Hospital	Nagoya	Aichi
Japan	Japanese Red Cross Narita Hospital	Narita	Chiba
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Okayama Medical Center	Okayama
Japan	Osaka Red Cross Hospital	Osaka
Japan	Kinki University Hospital, Faculty of Medicine	Osakasayama	Osaka
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Nishigunma National Hospital	Shibukawa	Gunma
Japan	Shizuoka Cancer Center	Sunto	Shizuoka
Japan	National Disaster Medical Center	Tachikawa	Tokyo
Japan	Japanese Red Cross Medical Center	Tokyo
Japan	Keio University Hospital	Tokyo
Japan	National Cancer Center Hospital	Tokyo
Japan	The Cancer Institute Hospital of Japanese Foundation for Cancer Research	Tokyo
Japan	Ehime University Hospital	Touon	Ehime

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Suzuki K, Shinagawa A, Uchida T, Taniwaki M, Hirata H, Ishizawa K, Matsue K, Ogawa Y, Shimizu T, Otsuka M, Matsumoto M, Iida S, Terui Y, Matsumura I, Ikeda T, Takezako N, Ogaki Y, Midorikawa S, Houck V, Ervin-Haynes A, Chou T. Lenalidomide and low-dose de — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and = 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or = 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: = 50% reduction of serum M-Protein and reduction in urinary M-protein by = 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a = 50% reduction in the size of soft tissue plasmacytomas is also required.	From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.
Secondary	Time to Response	Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR).; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and = 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or = 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: = 50% reduction of serum M-Protein and reduction in urinary M-protein by = 90% or to < 200 mg/24 hours. If present at baseline a = 50% reduction in size of soft tissue plasmacytomas is also required.	From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.
Secondary	Duration of Response	Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.	From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.
Secondary	Progression Free Survival (PFS)	PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.	From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.
Secondary	Overall Survival (OS)	The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.	From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months
Secondary	Number of Participants With Adverse Events	An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.	From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks